US9757186B2 - Device status feedback for bipolar tissue spacer - Google Patents

Abstract

A surgical instrument includes an end effector and a feedback system. The end effector includes a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector during a closure stroke between an open configuration, a first approximated configuration, and a second approximated configuration. The feedback system includes an indicator, the indicator transitionable between a first indicator position, a second indicator position, and a third indicator position, wherein the indicator is in the first indicator position when the end effect is in the open configuration, wherein the indicator is in the second indicator position when the end effector is in the first approximated configuration, and wherein the indicator is in the third indicator position when the end effector is in the second approximated configuration.

Description

BACKGROUND

The present invention relates to surgical instruments and, in various circumstances, to surgical sealing and transecting instruments.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of instances of the invention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates a perspective view of a surgical instrument comprising a handle and an end effector assembly;

FIG. 2 illustrates a perspective view of the surgical instrument ofFIG. 1;

FIG. 3 illustrates a partial side view of the surgical instrument ofFIG. 1;

FIG. 4 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 5 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 5A illustrates a feedback system including an indicator circuit for use with the surgical instrument ofFIG. 1;

FIG. 5B illustrates a feedback system for use with the surgical instrument ofFIG. 1;

FIG. 6 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 7 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 8 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 9 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 10 illustrates a feedback system including an indicator circuit for use with the surgical instrument ofFIG. 1;

FIG. 11 illustrates a partial side view of a handle assembly of the surgical instrument ofFIG. 1 with a removed housing shroud;

FIG. 12 illustrates a side view of an end effector assembly and a partial shaft assembly of the surgical instrument ofFIG. 1 including an indicator visible through an indicator window;

FIG. 13 illustrates a feedback system for use with the surgical instrument ofFIG. 1;

FIG. 14 illustrates an indicator of a feedback system of the surgical instrument ofFIG. 1 in a plurality of indicator positions relative to an indicator window; and

FIG. 15 illustrates an indicator of a feedback system of the surgical instrument ofFIG. 1 in a plurality of indicator positions relative to an indicator window.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a surgical system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of a system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.

The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device that has a working channel through which the end effector and elongated shaft of a surgical instrument can be advanced.

Turning to the Drawings wherein like numerals denote like components throughout the several views,FIG. 1 depicts one form of anelectrosurgical instrument2. Theelectrosurgical instrument2 comprises ahandle assembly4, ashaft assembly12 coupled to a distal end of thehandle assembly4, and anend effector10 coupled to the distal end of theshaft assembly12. Thehandle assembly4 is configured as a pistol grip and comprises left and righthandle housing shrouds6a,6b, aclosure trigger8, a pistol-grip handle14, afiring trigger16, anenergy button18, and arotatable shaft knob20. An electrical cable may enter thehandle assembly4 at a proximal end.

In some circumstances, theend effector10 can be coupled to the distal end of theshaft assembly12. Theend effector10 may include afirst jaw22aand asecond jaw22b. Thefirst jaw22ais pivotably coupled to thesecond jaw22b. Thefirst jaw22ais pivotally moveable with respect to thesecond jaw22bto grasp tissue therebetween. In some circumstances, thesecond jaw22bis fixed. In other circumstances, thefirst jaw22aand thesecond jaw22bare pivotally movable. Theend effector10 may include at least oneelectrode92. Theelectrode92 is configured to deliver energy. Energy delivered by theelectrode92 may comprise, for example, radiofrequency (RF) energy, sub-therapeutic RF energy, ultrasonic energy, and/or other suitable forms of energy. In some circumstances, a cutting member (not shown) is receivable within a longitudinal slot defined by thefirst jaw22aand/or thesecond jaw22b. The cutting member can be configured to cut tissue grasped between thefirst jaw22aand thesecond jaw22b. In some circumstances, the cutting member may include an electrode for delivering energy, such as, for example, RF and/or ultrasonic energy.

In certain instances, anenergy button18 is configured to deliver energy to the at least oneelectrode92 coupled to theend effector10 from a power source. In certain instances, when theenergy button18 is depressed, a circuit is completed allowing delivery of energy to theelectrode92. In some embodiments, the power source is a generator. In certain instances, the generator is external to thesurgical instrument2 which is separably coupled to the generator. In other instances, the generator is integrated with thesurgical instrument2. In certain instances, feedback systems described by the present disclosure comprise indicators which are housed within the generator and can be separably coupled to thesurgical instrument2 in the instances where the generator is separably coupled to thesurgical instrument2, for example. In certain instances, the power source may be suitable for therapeutic tissue treatment, tissue cauterization/sealing, as well as sub-therapeutic treatment and measurement.

In certain instances, thesurgical instrument2 may include a closure drive assembly which may comprise anouter sheath23, for example. In certain instances, theclosure trigger8 can be operatively coupled to at least one of thejaws22a,22bthrough the closure drive assembly such that actuation of the closure trigger8 in a closure stroke may transition thejaws22a,22bbetween a plurality of configurations including an open configuration and an approximated configuration, for example. In certain instances, thesurgical instrument2 may include a firing drive assembly. In certain instances, the firingtrigger16 may be operatively coupled to the cutting member of theend effector10 through the firing drive assembly such that actuation of the firingtrigger16 in a firing stroke may cause the cutting member to be advanced relative to theend effector10 to cut tissue captured between thejaws22a,22b, for example.

FIG. 2 illustrates a side perspective view of theelectrosurgical instrument2 illustrated inFIG. 1.FIG. 2 illustrates theright handle housing6b. Theenergy button18 extends through thehandle assembly4 and is accessible on both sides of thehandle assembly4. Theclosure trigger8, the firingtrigger16, and theenergy button18 may comprise an ergonomic design. In some circumstances, thehandle assembly4 is thinner near theenergy button18 to allow ease of access to theenergy button18 by a clinician. In some circumstances, theenergy button18 is disposed on either theleft handle housing6aor theright handle housing6b.FIG. 3 illustrates a side view of theelectrosurgical instrument2 and theright handle housing6b. Various electrosurgical instruments suitable for use with the present disclosure are described in U.S. patent application Ser. Nos. 14/075,839 and 14/075,863. U.S. patent application Ser. No. 14/075,839, entitled ELECTROSURGICAL DEVICES, and filed Nov. 8, 2013, is hereby incorporated by reference herein in its entirety. Furthermore, U.S. patent application Ser. No. 14/075,863, entitled ELECTROSURGICAL DEVICES, and filed Nov. 8, 2013, is hereby incorporated by reference herein in its entirety.

FIG. 4 illustrates one embodiment of thesurgical instrument2 ofFIG. 1 with theleft handle housing6aremoved. Thehandle assembly4 comprises a plurality of components for actuating thesurgical instrument2, such as, for example, mechanisms for affecting closure of thejaws22a,22bof theend effector10, deploying the cutting member within theend effector10, and/or delivering energy to the one ormore electrodes92 coupled to theend effector10. In certain instances, aclosure trigger8 may be operably coupled to a closure drive assembly which can be configured to transition thejaws22a,22bbetween an open configuration and an approximated configuration. In certain instances, theclosure trigger8 is connected to a closure actuator located within thehandle assembly4. In certain instances, the closure actuator comprises atoggle arm24 which may be coupled to theclosure trigger8 at afirst pivot25 and to ayoke26 at asecond pivot27. In certain instances, the closure actuator may comprise any suitable actuator for coupling theclosure trigger8 to a jaw actuator of the shaft assembly. For example, in some embodiments, the closure actuator comprises an L-shaped lever arm. In certain instances, when theclosure trigger8 is actuated towards the pistol grip handle14, thetoggle arm24 may drive movement of theyoke26 in a first direction along a longitudinal axis L-L. Longitudinal movement of theyoke26 in the first direction may drive a closure drive, such as, for example, theouter sheath23, to transition thejaws22a,22bfrom the open configuration to the approximated configuration, for example. Furthermore, the longitudinal movement of theyoke26 in a second direction, opposite the first direction, may drive the closure drive to transition thejaws22a,22bfrom the approximated configuration to the open configuration, for example.

In certain instances, a firingtrigger16 is configured to deploy the cutting member within theend effector10. The firingtrigger16 can be operatively coupled to firing drive assembly including, for example, acompound gear42, as illustrated inFIG. 4. Thecompound gear42 may interface with arack44, for example. Therack44 can be coupled to a firing drive which may extend through theouter sheath23 and may transmit axial motions to the cutting member of theend effector10. In certain instances, when the firingtrigger16 is actuated, thecompound gear42 rotates and moves therack44 distally. The distal movement of therack44 may cause distal movement of the firing drive and deployment of the cutting member within theend effector10. The cutting member can be deployed from a proximal end of theend effector10 to a distal end of theend effector10. In certain instances, the firingtrigger16 comprises a high pivot to provide a linear feel during actuation of the firingtrigger16. The linear feel provides increased control and comfort to a clinician actuating the firingtrigger16.

In certain instances, thecompound gear42 can be operably coupled to a motor (not shown). Rotational motions generated by the motor may cause therack44 to be advanced distally, and in turn cause the cutting member to be deployed from the proximal end of theend effector10 to the distal end of theend effector10, for example. In certain instances, the motor can be powered by a power source such as, for example, a battery (not shown). In certain instances, the firingtrigger16 may comprise a switch (not shown), for example, which can be operably coupled to a circuit, for example, such that movement of the firingtrigger16 from a first position to a second position may cause the switch to close the circuit which may activate the motor to deploy the cutting member, for example.

Referring toFIGS. 4 and 5, in some instances, thesurgical instrument2 may comprise a locking mechanism which may be configured to engage the firing drive assembly to interfere with, resist, and/or prevent deployment of the cutting member of theend effector10. In certain instances, the locking mechanism may include a lockingmember38. In certain instances, the lockingmember38 can be transitioned between a locked configuration and an unlocked configuration; in the locked configuration, the lockingmember38 can be configured to engage arack unlock block40 of the firing drive assembly to interfere with, resist, and/or prevent deployment of the cutting member of theend effector10. In certain instances, as illustrated inFIG. 5, alock spring64 may be coupled to the lockingmember38 to apply a biasing force against the lockingmember38. The biasing force may bias the lockingmember38 to maintain a locking engagement with the firing drive assembly.

In certain instances, the closure drive assembly is movable to release the firing drive assembly by causing the lockingmember38 to transition from locking engagement with therack unlock block40, as illustrated inFIG. 5, to the unlocked configuration, as illustrated inFIG. 7, for example. In certain instances, the closure drive assembly may comprise an unlockingmember41 which may be movable to raise the lockingmember38 from locking engagement with therack unlock block40, for example. In other words, actuation of thetrigger8 may transition thejaw22a,22bto the approximated configuration and may release the locking mechanism of the firing drive assembly by causing the unlockingmember41 to motivate the lockingmember38 out of locking engagement with therack unlock block40, for example. In certain instances, when theclosure trigger8 is released and theyoke26 returns to a rest position, thelock spring64 may bias the lockingmember38 back into a locking engagement with therack unlock block40, for example.

In certain instances, the locking mechanism of thesurgical instrument2 may be employed as a safety mechanism which may prevent deployment of the cutting member of theend effector10 while thejaws22a,22bare in the open configuration and/or while thejaws22a,22bare not sufficiently transitioned to the closed configuration. In use, a clinician may orient theend effector10 to position thejaws22a,22baround a desired tissue to seal and cut the desired tissue. Furthermore, the clinician may actuate theclosure trigger8 to transition thejaws22a,22bfrom the open configuration toward the approximated configuration to clamp the desired tissue, for example. In certain instances, however, thesurgical instrument2 may not be appropriate for safely treating the clamped tissue. For example, the clamped tissue may comprise a thickness that is too large to be safely treated with thesurgical instrument2. In such instances, the locking mechanism may be employed to prevent deployment of the cutting member of theend effector10 to cut the clamped tissue if the clinician actuates the firingtrigger16 to deploy the cutting member to cut the clamped tissue. In other words, the thickness of the clamped tissue may not permit sufficient closure of thejaws22a,22baround the clamped tissue for thejaws22a,22bto reach the approximated configuration. Accordingly, the clinician may not be able to sufficiently actuate theclosure trigger8 to complete a closure stroke. In turn, the unlockingmember41 may not be sufficiently motivated to release the lockingmember38 out of locking engagement with therack unlock block40.

In certain instances, theyoke26 can be coupled to an unlockingmember41. In certain instances, when theyoke26 is moved in response to the actuation of theclosure trigger8, the lockingmember41 lifts the lockingmember38 vertically away from therack unlock block40. In certain instances, when the lockingmember38 has been lifted a sufficient distance, therack44 is allowed to move and the firingtrigger16 is actuatable to deploy the cutting member within theend effector10. In certain instances, the firingtrigger16 is unlocked when thejaws22a,22bare sufficiently closed such that the cutting member cannot skip out of a slot formed in theend effector10. For example, in some instances, the lockingmember38 is released when theclosure trigger8 is rotated about 30 degrees. In other instances, the lockingmember38 may be released at a lower or higher degree of rotation of theclosure trigger8. In certain instances, the firingtrigger16 is unlocked when the clamped tissue between thejaws22a,22bis sufficiently compressed to enable the cutting member to fully transect the clamped tissue. In certain instances, the firingtrigger16 is unlocked when the clamped tissue between thejaws22a,22bis sufficiently compressed to a thickness that is less than or equal, or at least substantially equal, to the height of the cutting surface of the cutting member of theend effector10, for example.

The reader will appreciate that it may be desirable to provide a clinician utilizing thesurgical instrument2 with feedback at various stages during operation of thesurgical instrument2. In certain instances, thesurgical instrument2 may comprise one or more mechanical feedback systems. In certain instances, thesurgical instrument2 may comprise one or more electrical feedback systems. In certain instances, thesurgical instrument2 may comprise combinations of mechanical feedback systems and electrical feedback systems. In certain instances, some of the feedback systems described herein may include one or more indicators. In certain instances, the indicators may comprise, for example, visual indicators such as display screens, backlights, and/or LEDs, for example. In certain instances, the indicators may comprise audio indicators such as speakers and/or buzzers, for example. In certain instances, the indicators may comprise tactile indicators such as haptic actuators, for example. In certain instances, the indicators may comprise combinations of visual indicators, audio indicators, and/or tactile indicators, for example.

In certain instances, one or more of the feedback systems of thesurgical instrument2 may be configured to alert a clinician actuating theclosure trigger8 if a tissue bite clamped by theend effector10 comprises a thickness that is too large for proper treatment via thesurgical instrument2. In certain instances, one or more of the feedback systems of thesurgical instrument2 may be configured to alert a clinician actuating the firingtrigger16 if the firing drive assembly is locked by the locking mechanism of thesurgical instrument2. For example, the one or more of the feedback systems of thesurgical instrument2 may be configured to alert the clinician actuating the firingtrigger16 if the lockingmember38 is in locking engagement with therack unlock block40. In certain instances, one or more of the feedback systems of thesurgical instrument2 may be configured to alert a clinician actuating theclosure trigger8 when the firing drive assembly becomes unlocked. In other words, one or more of the feedback systems of thesurgical instrument2 may be configured to alert a clinician actuating theclosure trigger8 when thejaws22a,22bare sufficiently closed such that therack unlock block40 is released from locking engagement with lockingmember38.

Referring toFIGS. 5-7, thesurgical instrument2 may comprise an electrical feedback system202 (FIG. 5A). In certain instances, thesystem202 may include anindicator circuit204 which may comprise anindicator205. In certain instances, thecircuit204 may include a plurality of switches such as, for example, normally open, normally closed, and/or other switch types. In certain instances, thecircuit204 may include aswitch206 which may be associated with the firingtrigger16, for example. In certain instances, as illustrated inFIG. 5A, theswitch206 can be transitioned between an inactive or open configuration orposition206aand an active or closed configuration orposition206b. In certain instances, theswitch206 can be coupled to the firingtrigger16 such that actuation of the firingtrigger16 between an unactuated position and a first actuated position during the firing stroke may cause theswitch206 to move from theinactive configuration206ato theactive configuration206b. In certain instances, the actuation of the firingtrigger16 from the unactuated position to the first actuated position may be a slight actuation that may not cause movement of the cutting member of theend effector10 or may cause a slight movement of the cutting member of theend effector10 that may not cause the cutting member to be sufficiently advanced to cut tissue clamped between thejaws22a,22b.

Referring again toFIGS. 5-7, in certain instances, thecircuit204 may include aswitch208 which may be associated with the lockingmember38, for example. In certain instances, as illustrated inFIG. 5A, theswitch208 can be transitioned between an inactive or open configuration orposition208aand an active or closed configuration orposition208b.

As described above, the lockingmember38 can be transitioned between the locked position, wherein the lockingmember38 is in locking engagement with the firing drive assembly, and the unlocked position, wherein firing drive assembly is released from locking engagement with the lockingmember38. In certain instances, theswitch208 can be coupled to the lockingmember38 such that theswitch208 remains in theactive configuration208bwhile the lockingmember38 is in the locked configuration. Furthermore, theswitch208 may be transitioned from theactive configuration208bto theinactive configuration208awhen the lockingmember38 is transitioned from the locked configuration to the unlocked configuration, for example.

Referring primarily toFIG. 5A, in certain instances, theindicator circuit204 is closed and theindicator205 is activated when theswitch206 and theswitch208 are both in the active configuration, for example. In certain instances, theindicator circuit204 is open and theindicator205 is inactive if one of theswitch206 and theswitch208 is in the inactive configuration, for example. In certain instances, theindicator circuit204 is open and theindicator205 is inactive if both of theswitches206 and208 are in the inactive configuration, for example.

In certain instances, when the lockingmember38 is in the locked configuration and the firingtrigger16 is in the first actuated position, theindicator circuit204 is closed and theindicator205 is activated. For example, a clinician may actuate theclosure trigger8 to clamp tissue comprising a thickness that is too large for proper treatment via thesurgical instrument2. In such instances, the lockingmember38 may remain in the locked configuration because the unlockingmember41 has not been sufficiently moved by theclosure trigger8 to separate the lockingmember38 from locking engagement with the firing drive assembly, as described above. In result, theswitch208 may remain in theactive configuration208b. In such instance, if the clinician attempts to actuate the firingtrigger16 from the unactuated position to the first actuated position, as described above, theswitch206 may also be transitioned to theactive configuration206bwhich may cause theindicator circuit204 to be closed and theindicator205 to be activated to alert the clinician that the cutting member cannot be advanced to cut tissue captured by theend effector10 because the firing drive assembly is locked, for example. In other words, theindicator205 may alert the clinician that thejaws22a,22bare too far apart and that the cutting member cannot be advanced. In response, the clinician may release the captured tissue and may attempt to capture a more suitable tissue target, for example.

The reader will appreciate that if the captured tissue is not too large for proper treatment with thesurgical instrument2, theclosure trigger8 may be sufficiently actuated to allow the unlockingmember41 to sufficiently motivate the lockingmember38 to the unlocked configuration to release therack unlock block40 and free the firing drive assembly. The transitioning of the lockingmember38 to the unlocked configuration causes theswitch208 to be transitioned to theinactive configuration208a. In such instance, if the clinician attempts to actuate the firingtrigger16 from the unactuated position to the first actuated position, as described above, theswitch206 may be transitioned to theactive configuration206bbut since theswitch208 is in theinactive configuration208a, theindicator circuit204 will not be closed and theindicator205 will not be activated; and since the firing drive assembly is free from locking engagement with the lockingmember38, the clinician may continue actuating the firingtrigger16 to advance the cutting member of theend effector10 to cut the tissue captured between thejaws22a,22b, for example. In other words, theindicator205 is not activated since thejaws22a,22bare sufficiently closed around captured tissue and, accordingly, the firingtrigger16 can be fully actuated in a complete firing stroke to advance the cutting member of theend effector10 to cut the captured tissue.

In certain instances, as illustrated inFIG. 5B, theindicator205, theswitch206, and theswitch208 can be operably coupled to a microcontroller220 (“controller”), for example. In certain instances, thecontroller220 may include a microprocessor222 (“processor”) and one ormore memory units224 operationally coupled to theprocessor222, for example. A power source such as, for example, abattery226 can be configured to supply power to thecontroller220 and/or theindicator205, for example. In certain instances, thememory224 may include program instructions that can be executed from thememory224 to cause theprocessor220 to transmit activation signals to theindicator205 in response to simultaneous active signals received from theswitches206 and208, for example.

Thecontroller220 may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate arrays (FPGA), logic gates, registers, semiconductor devices, chips, microchips, chip sets, microcontrollers, system-on-chip (SoC), and/or system-in-package (SIP). Examples of discrete hardware elements may include circuits and/or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In certain instances, thecontroller220 may include a hybrid circuit comprising discrete and integrated circuit elements or components on one or more substrates, for example.

In certain instances, themicrocontroller220 may be an LM 4F230H5QR, available from Texas Instruments, for example. In certain instances, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprising on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels, among other features that are readily available. Other microcontrollers may be readily substituted for use with the present disclosure. Accordingly, the present disclosure should not be limited in this context.

Referring toFIGS. 8 and 9, in certain instances, thesurgical instrument2 may comprise one or more mechanical feedback systems such as, for example, amechanical feedback system212. In certain instances, themechanical feedback system212 may replace theelectrical feedback system202, for example. In certain instances, themechanical feedback system212 can be employed to provide feedback to a clinician using thesurgical instrument2 as to the whether the firing drive assembly is locked, for example.

As illustrated inFIG. 8, themechanical feedback system212 may include anindicator window214 positioned on an outer wall of thehandle housing4, for example. In addition, themechanical feedback system212 may include a lockedindicator216 which indicates that the firing drive assembly is locked, for example, and anunlocked indicator218 which indicates that the firing drive assembly is unlocked, for example. In certain instances, as illustrated inFIG. 8, theindicators216 and218 can be operably coupled to the lockingmember38. For example, as illustrated inFIG. 8, theindicators216 and218 can be pivotally coupled to the lockingmember38 via apivot member220. In certain instances, theindicators216 and218 can be operably movable with the lockingmember38 and can be aligned with theindicator window214 such that the lockedindicator216 is visible from theindicator window214, as illustratedFIG. 8, while the lockingmember38 is in the locked configuration, and theunlocked indicator218 is visible from theindicator window214, as illustrated inFIG. 9, while the lockingmember38 is in the unlocked configuration, for example.

In some instances, thejaws22a,22bare configured to maintain a minimal spacing therebetween to prevent damage to components of thesurgical instrument2 and/or the tissue section. In some instances, full actuation of theclosure trigger8 corresponds to a rotation of about 30 degrees. When theclosure trigger8 is fully rotated against the pistol grip handle14, aclosure trigger lock46 is engaged to maintain thejaws22a,22bin a closed position. Once thetrigger lock46 has been engaged, the clinician may release theclosure trigger8 and thetrigger lock46 maintains theclosure trigger8 in a closed position.

In certain instances, thetrigger lock46 may maintain theclosure trigger8 in a less than fully retracted position to prevent damage to components of thesurgical instrument2 due to over application of force to thejaws22a,22b. Thetrigger lock46 may maintain theclosure trigger8 in a sufficiently rotated position to release the lockingmember38 from therack unlock block40. For example, in the some instances, thetrigger lock46 maintains theclosure trigger8 at a rotation of about 28 degrees. With theclosure trigger8 in a locked position, the clinician may actuate the firingtrigger16 to deploy the cutting member within theend effector10. In some instances, the clinician may actuate theenergy button18 to deliver energy to a tissue section grasped between thejaws22a,22bprior to or simultaneously with, deployment of the cutting member.

Referring toFIGS. 10 and 11, thesurgical instrument2 may include closure feedback systems that are associated with theclosure trigger8 such as, for example, anelectrical feedback system240 and/or amechanical feedback system242. As described above, theclosure trigger8 is actuatable between an initial unactuated position and an actuated locked position to close thejaws22a,22baround tissue, for example. In certain instances, theclosure feedback systems240 and/or242 may be configured to warn or alert a clinician actuating thetrigger8 in the event the captured tissue comprises a thickness that cannot be properly treated utilizing thesurgical instrument2. In certain instances, theclosure feedback systems240 and/or242 may be configured to warn or alert a clinician actuating thetrigger8 in the event the tissue captured between thejaws22a,22bcannot be safely compressed to a thickness that is less than or equal, or at least substantially equal, to the height of the cutting surface of the cutting member of theend effector10, for example. In certain instances, theclosure feedback systems240 and/or242 may be configured to warn or alert a clinician if the actuation force exerted against thetrigger8 by the clinician exceeds a safe threshold, for example. In certain instances, theclosure feedback systems240 and/or242 may be configured to warn or alert a clinician actuating thetrigger8 in the event the tissue captured between thejaws22a,22bprevents approximation for theend effector10 during a closure stroke from a first approximated configuration, for example, to a second approximated configuration, for example. In certain instances, the first approximated configuration corresponds to a tissue thickness that is not safely treatable by thesurgical instrument2; and the second approximated configuration corresponds to a tissue thickness that is safely treatable by thesurgical instrument2.

Referring toFIG. 10, theelectrical feedback system240 may include anindicator circuit244. In certain instances, theindicator circuit244 may comprise anindicator245. In certain instances, thecircuit244 may include a plurality of switches such as, for example, normally open, normally closed, and/or other switch types. In certain instances, thecircuit244 may include aswitch246 which may be associated with theclosure trigger8, for example. In certain instances, theswitch246 can be transitioned between an inactive or open configuration orposition246aand an active or closed configuration orposition246b, as illustrated inFIG. 10. In certain instances, theswitch246 can be coupled to theclosure trigger8 such that actuation of theclosure trigger8 between the initial unactuated position and the actuated locked position during the closure stroke may cause theswitch246 to move from theinactive configuration246ato theactive configuration246b, for example.

Further to the above, as illustrated inFIG. 10, thecircuit244 may comprise aswitch248. In certain instances, theswitch248 can be transitioned between a first inactive or open configuration orposition248a, an active or closed configuration orposition248b, and a second inactive or open configuration orposition248cduring the closure stroke, for example. In certain instances, theswitch248 can be associated with one of thejaws22a,22b, for example. In certain instances, theswitch248 can be coupled to thejaw22a, for example, such that motion of thejaw22aduring the closure stroke from an open unactuated or initial position to a first actuated position may cause theswitch248 to be transitioned from the firstinactive configuration248a, for example, to theactive configuration248b, for example; and motion of thejaw22aduring the closure stroke beyond the first actuated position to a second actuated position, for example, may cause theswitch248 to be transitioned from theactive configuration248b, for example, to the secondinactive configuration248c, for example. In certain instances, thecircuit244 can be closed and theindicator245 can be activated when theswitches246 and248 are in theclosed configurations246band248b, respectively.

In use, a clinician may position thejaws22a,22baround tissue and may actuate theclosure trigger8 through a closure stroke to actuate thejaws22a,22bto clamp the tissue, for example. In certain instances, the first actuated position of thejaw22acan be associated with a first tissue thickness, for example; and the second actuated position of thejaw22acan be associated with a second tissue thickness, for example. In certain instances, the first tissue thickness is too large for proper treatment with thesurgical instrument2. In certain instances, the second tissue thickness is suitable for treatment with thesurgical instrument2. In certain instances, if the tissue clamped between thejaws22a,22bcomprises the first tissue thickness, thejaw22amay remain in the first actuated position and may not be able to transition beyond the first actuated position to the second actuated position, as the clinician continues to actuate thetrigger8, due to the large thickness of the tissue clamped between thejaws22a,22b. Accordingly, theswitch248 may remain in theactive configuration248b, for example. If the clinician continues actuating theclosure trigger8 through the remainder of the actuation stroke, theclosure trigger8 may ultimately reach the actuated locked position; at such instance, theswitch246 may reach theactive configuration246band since theswitch248 is also in theactive configuration248b, thecircuit244 will become closed and theindicator245 activated to alert the clinician that the captured tissue comprises a thickness that is too large for proper treatment with thesurgical instrument2.

The reader will appreciate that if the tissue clamped between thejaws22a,22bcomprises a thickness suitable for treatment via theinstrument2 such as, for example, the second tissue thickness, thejaw22amay continue to move past the first actuated position and toward the second actuated position as the clinician continues to actuate thetrigger8 through the closure stroke. Accordingly, theswitch248 may move past theactive configuration248bto theinactive configuration248c. If the clinician continues actuating theclosure trigger8 through the remainder of the actuation stroke, theclosure trigger8 may ultimately reach the actuated locked position; at such instance, theswitch246 may reach theactive configuration246b. But since theswitch248 is in theinactive configuration248c, thecircuit244 will remain open and theindicator245 will remain inactive when theswitch246 reaches theclosed configuration246b. In other words, since the tissue clamped between thejaws22a,22bcomprises a thickness that is not too large for treatment with thesurgical instrument2, theindicator245 may remain inactive.

In certain instances, theswitch248 can be associated with the closure drive assembly at a position proximal to thejaw22aand can be operable in a similar manner as described above. In certain instances, theswitch248 can be associated with thejaw22band can be operable in a similar manner as described above. In certain instances, thecircuit244 may comprise a third switch (not shown) which can be associated with thejaw22bsuch that thecircuit244 is closed and theindicator245 is activated when the third switch and theswitches246 and248 are all in the active configuration, for example.

Referring toFIG. 11, in certain instances, themechanical feedback system242 may replace theelectrical feedback system240, for example, to provide feedback to a clinician actuating thetrigger8 in the event the tissue clamped between thejaws22a,22bcomprises a thickness that cannot be properly treated with thesurgical instrument2. As illustrated inFIG. 11, themechanical feedback system242 may include anindicator window264 positioned on an outer wall of thehandle housing4, for example. In certain instances, as illustrated inFIG. 12, theindicator window264 can be positioned on theouter sheath23 of theshaft assembly12, for example.

In any event, themechanical feedback system242 may include anindicator266. In certain instances, as illustrated inFIGS. 14 and 15, theindicator266 can be movable between afirst indicator position280, asecond indicator position282, and athird indicator position284, for example. In certain instances, as illustrated inFIG. 15, theindicator266 is not visible through theindicator window264 while in thefirst indicator position280 and while in thethird indicator position284. However, in certain instances, theindicator266 is visible through theindicator window264 while in thesecond indicator position282, for example. In certain instances, theindicator266 is movable between a plurality of indicator positions that may be defined by color coded sections depicted on theouter sheath23, for example.

In certain instances, as illustrated inFIG. 11, theindicator266 can be movably coupled to the closure drive assembly via anindicator arm268, for example. In certain instances, theindicator266 can be pivotally coupled to the closure drive assembly of thesurgical instrument2 such that motion of the closure drive assembly between a first closure position corresponding to the unactuated open position of thejaw22a, a second closure position corresponding to the first actuated position of thejaw22a, and a third closure position corresponding to the second actuated position of thejaw22amay cause theindicator266 to move between the first indicator position, the second indicator position, and the third indicator position, respectively, for example.

In use, a clinician may position thejaws22a,22baround tissue and may actuate theclosure trigger8 through a closure stroke to actuate thejaws22a,22bto clamp the tissue, for example. As the clinician actuates thetrigger8, the closure drive assembly may be transitioned from the first closure position to the second closure position which may cause thejaw22ato be transitioned from the initial unactuated position to the first actuated position, and may cause theindicator266 to be transitioned from thefirst indicator position280 to thesecond indicator position282. As described above, theindicator266 may be visible through theindicator window264 in thesecond indicator position282. Also described above, if the tissue clamped between thejaws22a,22bcomprises the first tissue thickness, thejaw22amay remain in the first actuated position and may not be able to transition to the second actuated position, as the clinician continues to actuate thetrigger8, due to the large thickness of the tissue clamped between thejaws22a,22b. Accordingly, theindicator266 may remain in thesecond indicator position282 and may remain visible through theindicator window264 to provide the clinician with feedback that the captured tissue cannot be properly treated withsurgical instrument2, for example.

The reader will appreciate that if the tissue clamped between thejaws22a,22bcomprises a thickness suitable for treatment with theinstrument2 such as, for example, the second tissue thickness, the closure drive assembly may continue to move past the second closure position to the third closure position, for example, and thejaw22amay continue to move past the first actuated position to the second actuated position, for example, as the clinician continues to actuate thetrigger8 through the closure stroke. In result, theindicator266 may be moved past thesecond indicator position282 toward thethird indicator position284, for example, and away fromindicator window264.

In certain instances, referring toFIG. 13, thesurgical instrument2 may include one or more feedback systems such as, for example, afeedback system270. In certain instances, as illustrated inFIG. 13, thefeedback system270 may include thecontroller220 which may include theprocessor222 and thememory224, for example. In certain instances, thefeedback system270 can be powered by a power source such as, for example, thebattery226. In certain instances, thefeedback system270 may comprise one or more indicators such as, for example, theindicator205. In certain instances, thefeedback system270 may comprise one or more load cells such as, for example,strain gauges272 and274.

Strain gauges suitable for use in the present invention include (a) feedback electroactive polymer elements whose impedance or resistance varies as a function of the amount of strain in the device and (b) conventional strain gauges in which the resistance of the device varies as a function of the amount of strain in the device, thus allowing the amount of strain to be readily quantified and monitored. Such strain gauges are commercially from a number of different sources, including National Instruments Co., Austin, Tex., and include piezoresistive strain gauges (for which resistance varies nonlinearly with strain) and bonded metallic strain gauges (for which resistance typically varies linearly with strain). The later strain gauges consist of very fine wire or metallic foil that is arranged in a grid pattern. The grid is bonded to a thin backing or carrier, which may be directly attached to the substrate being monitored for strain. Consequently, the strain experienced by the substrate is transferred directly to the strain gauge, which responds with a change in electrical resistance. Commercially available strain gauges typically have nominal resistance values within the range of 30 to 3000Ω, with 120Ω, 350Ω and 1000Ω devices being especially common.

In certain instances, thestrain gauge272 is operable to monitor closure actuation forces applied by a clinician to thesurgical instrument2 through theclosure trigger8, for example. In certain instances, thestrain gauge272 can be placed on various locations of thesurgical instrument2 that are associated with the closure stroke. In certain instances, thestrain gauge272 can be placed on the closure drive, for example. In certain instances, thestrain gauge272 can be placed on theclosure trigger8, for example. In certain instances, thestrain gauge272 can be placed ontoggle arm24, for example.

In certain instances, thestrain gauge274 is operable to monitor firing actuation forces applied by a clinician to thesurgical instrument2 through the firingtrigger16, for example. In certain instances, thestrain gauge274 can be placed on various locations of thesurgical instrument2 that are associated with the firing stroke. In certain instances, thestrain gauge274 can be placed on the firing drive, for example. In certain instances, thestrain gauge274 can be placed on the firingtrigger16, for example.

In certain instances, thememory224 may include program instructions that can be executed from thememory224 to cause theprocessor220 to monitor strain measurements transmitted from thestrain gauge272 and/or thestrain gauge274 to theprocessor222. In certain instances, the strain measurements of thestrain gauge272 and/or thestrain gauge274 can be transmitted to theprocessor222 through an analogue to digital converter, for example. In certain instances, thememory224 may include program instructions that can be executed from thememory224 to cause theprocessor220 to detect an increase in the monitored closure actuation forces beyond a predetermined threshold and to transmit an activation signal to theindicator205 in response to the detection of such an increase. In certain instances, thememory224 may include program instructions that can be executed from thememory224 to cause theprocessor220 to detect an increase in the monitored firing actuation forces beyond a predetermined threshold and to transmit an activation signal to theindicator205 in response to the detection of such increase.

The reader will appreciate one or more of the switches described by the present disclosure may comprise mechanical switches, electro-mechanical switches, and/or solid state switches. In certain instances, one or more of the switches of the present disclosure may comprise open, inactive, and/or non-conductive positions, states, and/or configurations. In certain instances, one or more of the switches of the present disclosure may comprise closed, active, and/or conductive positions, states and/or configurations. In certain instances, one or more of the switches of the present disclosure can be transitioned from the open, inactive, and/or non-conductive positions, states, and/or configurations to the closed, active, and/or conductive positions, states and/or configurations to close and/or activate one or more circuits associated with such switches, for example.

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims (17)

What is claimed is:

1. A surgical instrument, comprising:

a shaft;

an end effector extending distally from the shaft, the end effector comprising:

a first jaw;

a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector between an open configuration and an approximated configuration;

an electrode operable to seal tissue captured between the first jaw and the second jaw in the approximated configuration; and

a cutting member movable to cut the tissue captured between the first jaw and the second jaw in the approximated configuration;

a housing extending proximally from the shaft, the housing comprising:

a closure trigger actuatable in a closure stroke to transition the end effector from the open configuration to the approximated configuration, the closure trigger movable between an initial unactuated position and an actuated position during the closure stroke; and

a firing trigger actuatable in a firing stroke to advance the cutting member to cut the tissue captured between the first jaw and the second jaw in the approximated configuration; and

a feedback system comprising an indicator circuit, the indicator circuit comprising:

a first switch transitionable between a first switch inactive configuration and a first switch active configuration, the first switch associated with the closure trigger, wherein the actuation of the closure trigger from the initial unactuated position to the actuated position transitions the first switch from the first switch active configuration to the first switch inactive configuration;

a second switch transitionable between a second switch inactive configuration and a second switch active configuration, the second switch associated with the firing trigger, wherein actuation of the firing trigger transitions the second switch from the second switch inactive configuration to the second switch active configuration; and

an indicator activated when the first switch is in the first switch active configuration and when the second switch is in the second switch active configuration.

2. The surgical instrument ofclaim 1, further comprising a locking member movable between a locked position and an unlocked position.

3. The surgical instrument ofclaim 2, wherein the locking member, in the locked position, is configured to resist advancement of the cutting member to cut the tissue captured between the first jaw and the second jaw in the approximated configuration.

4. The surgical instrument ofclaim 3, wherein the first switch is in the first switch active configuration when the locking member is in the locked position.

5. The surgical instrument ofclaim 4, wherein the first switch is in the first switch inactive configuration when the locking member is in the unlocked position.

6. The surgical instrument ofclaim 1, wherein the firing trigger is actuatable during the firing stroke to a first actuated position and to a second actuated position beyond the first actuated position.

7. The surgical instrument ofclaim 6, wherein the second switch is in the second switch active configuration when the firing trigger is in the first actuated position.

8. The surgical instrument ofclaim 7, wherein the cutting member comprises a cutting surface, and wherein the cutting surface is configured to contact the tissue when the firing trigger is in the second actuated position.

9. A surgical instrument, comprising:

an end effector, the end effector transitionable between an open configuration, a first approximated configuration, and a second approximated configuration;

a closure drive assembly movable in a closure stroke to transition the end effector from the open configuration to the first approximated configuration and further to the second approximated configuration;

a cutting member;

a firing drive assembly;

a firing trigger operably coupled to the firing drive assembly, the firing trigger actuatable in a firing stroke between an initial unactuated position, a first actuated position, and a second actuated position, wherein the firing trigger is movable from the first actuated position to the second actuated position to motivate the firing drive assembly to advance the cutting member to engage tissue captured by the end effector in the second approximated configuration; and

a feedback system comprising an indicator circuit, the indicator circuit comprising:

a first switch transitionable between a first switch open position and a first switch closed position, wherein the first switch is in the first switch closed position when the end effector is in the first approximated configuration, and wherein the first switch is in the first switch open position when the end effector is in the second approximated configuration;

a second switch transitionable between a second switch open position and a second switch closed position, wherein the second switch is in the second switch open position when the firing trigger is in the initial unactuated position, and wherein the second switch is in the second switch closed position when the firing trigger is in the first actuated position; and

an indicator activated when the first switch is in the first switch closed position and when the second switch is in the second switch closed position.

10. The surgical instrument ofclaim 9, further comprising a locking member movable between a locked position and an unlocked position.

11. The surgical instrument ofclaim 10, wherein the locking member is in the locked position when the end effector is in the first approximated configuration.

12. The surgical instrument ofclaim 11, wherein the locking member is in the unlocked position when the end effector is in the second approximated configuration.

13. The surgical instrument ofclaim 12, wherein the locking member is configured to engage the firing drive assembly in the locked position.

14. The surgical instrument ofclaim 13, wherein the locking member is configured to release the firing drive assembly in the unlocked position.

15. The surgical instrument ofclaim 14, wherein the first switch is coupled to the locking member, wherein movement of the locking member from the locked position to the unlocked position transitions the first switch from the first switch closed position to the first switch open position.

16. A surgical instrument, comprising:

a shaft;

a handle extending proximally from the shaft, the handle comprising a closure trigger actuatable in a closure stroke between an initial unactuated position and a locked actuated position;

an end effector extending distally from the shaft, the end effector operably coupled to the closure trigger, wherein the end effector comprises:

a first jaw; and

a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw to transition the end effector during the closure stroke between an open configuration, a first approximated configuration, and a second approximated configuration; and

a feedback system including an indicator circuit, the indicator circuit comprising:

a first switch transitionable between a first open position, an intermediate closed position, and a second open position, wherein the first switch is in the first open position when the end effector is in the open configuration, wherein the first switch is in the intermediate closed position when the end effector is in the first approximated configuration, and wherein the first switch is in the second open position when the end effect is in the second approximated configuration;

a second switch transitionable between an open position and a closed position, wherein the second switch is in the open position when the closure trigger is in the initial unactuated position, and wherein the second switch is in the closed position when the closure trigger is in the locked actuated position; and

an indicator, the indicator activated when the first switch is in the intermediate closed position and when the second switch is in the closed position.

17. The surgical instrument ofclaim 16, wherein the first switch is movably coupled to the first jaw.

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